BLACKSBURG, Va. -- Landos Biopharma, Inc., a clinical-stage biopharmaceutical company focused on the discovery and development of therapeutics for patients with autoimmune diseases today announced dosing of the first patient in a Phase 2 study evaluating the safety and efficacy of BT-11 in patients with mild to moderate ulcerative colitis (UC). BT-11 is a novel, orally-administered, gut-restricted, first-in-class therapeutic in clinical development for UC and Crohn's disease (CD).
"Dosing the first ulcerative colitis patients in this Phase 2 study is a crucial milestone for Landos. We believe the Phase 1 clinical results reinforced BT-11's benign safety profile and showed a response to treatment based on lower concentrations of fecal calprotectin, which we believe is a predictive biomarker of therapeutic response and extended clinical remission in inflammatory bowel disease (IBD). We are excited to begin our first study in patients and to better understand the clinical utility of BT-11 in treating this important disease," said Dr. Josep Bassaganya-Riera, Chairman of the Board. President, and CEO of Landos.
The global Phase 2 study will utilize a randomized, placebo-controlled, double-blind, parallel-group, multicenter design to evaluate the safety, efficacy and tolerability of BT-11 compared to placebo in patients with mild to moderately-active UC. The study will enroll 195 UC patients with mild to moderate disease in 11 countries with 60 sites throughout the U.S., Europe and Eastern Europe. Patients will be randomized to receive one of two doses of BT-11 (500 or 1,000 mg) or placebo for a 12-week induction phase followed by a maintenance phase. The study's primary endpoint will assess the effect of treatment with once-daily doses of BT-11 tablets or placebo on clinical remission rate at week 12, as defined by total Mayo score ≤ 2 with all sub-scores ≤1.
"The medical community has long recognized the unmet need for safer, more convenient, and effective therapeutic alternatives to treating patients with ulcerative colitis," said Jean-Frederic Colombel, MD, a Landos Clinical Advisory Board member, world-renowned Gastroenterologist and Director of the IBD Center at the Icahn School of Medicine at Mount Sinai. "The Phase 1 data are consistent with a benign safety profile without systemic immunosuppression and an initial efficacy signal based on lower fecal calprotectin levels. If BT-11 shows efficacy in Phase 2/3 clinical trials, it could ultimately provide long-term benefit for millions of people living with IBD."
BT-11 is a first-in-class, orally-active, gut-restricted small molecule investigational new drug that targets the Lanthionine Synthetase C-Like 2 (LANCL2) pathway that impacts the gastrointestinal tract. LANCL2 plays an important role in the immunoregulatory process. By activating the LANCL2 pathway and modulating the interactions between immunological and metabolic signals in immune cells, BT-11 creates a favorable regulatory microenvironment in the gut, decreasing the production of key inflammatory mediators and increasing anti-inflammatory markers in regulatory T cells (Treg) within the site of inflammation. BT-11 has shown demonstrated therapeutic activity in 5 preclinical models of IBD, a benign safety profile without the concerns of systemic exposure in preclinical and Phase 1 clinical studies and has two open INDs for evaluation in UC and CD. The Company completed Phase 1 testing of BT-11 in 2018 and initiated Phase 2 testing in 2019.
About the Phase 2 Clinical Trial
This trial is a Phase 2 randomized, placebo-controlled, double-blind, parallel-group, multicenter induction study. A total of 195 subjects with mild to moderate UC (total Mayo Score 4-10; Mayo endoscopic subscore [MES] ≥ 2) will be randomized in a 1:1:1 ratio to receive BT-11 low-dose (500 mg), BT-11 high-dose (1,000 mg), or placebo tablets. Each treatment arm will comprise 65 subjects. The study consists of a 28-day screening period, a 12-week induction phase, and a 2-week post-treatment safety follow-up period. Primary outcomes will be safety and clinical remission as measured by total Mayo Clinic Score of Disease activity including centrally read endoscopy. Secondary outcomes include quantitative measurement of mucosal injury by endoscopy, mucosal healing, mean change in fecal calprotectin from baseline, and concentration of BT-11 in feces. Topline results from the study are expected in 2020.
About Ulcerative Colitis
Ulcerative colitis (UC) is a chronic inflammatory disease of the large intestine also known as the colon.1 UC is a result of an abnormal response by the body's immune system that sends white blood cells into the lining of the intestines where they produce chronic inflammation and ulcerations that cause abdominal discomfort and frequent emptying of the colon.1 UC affects millions of patients globally. Healthcare providers have treatment goals that target sustained symptom relief, suppress the inflammation of the colon and allow for tissues to heal. 1 There is an unmet clinical need for safer, more effective medications to treat UC as currently marketed therapeutics have a number of drawbacks: they only benefit a small number of the overall population, lose response effectiveness, or cause high rates of serious side effects, including cancer, infection, and death.
About Landos Biopharma
Landos Biopharma, Inc. is a clinical-stage biopharmaceutical company focused on the discovery and development of first-in-class, oral therapeutics for patients with autoimmune diseases. Landos' lead clinical asset, BT-11, is a first-in-class, oral therapeutic that acts locally in the gastrointestinal tract for treatment of inflammatory bowel disease (IBD). The company has completed Phase 1 clinical testing, initiated Phase 2 clinical testing of BT-11 for ulcerative colitis and plans a Phase 2 trial in Crohn's disease in 2019. Landos also has a robust pipeline of new compounds for other autoimmune diseases, several of which Landos anticipates will advance to IND in 2019. Landos is headquartered in Blacksburg, VA.
1 What is Ulcerative Colitis? Crohn's and Colitis Foundation Website. http://www.
Cautionary Note on Forward-Looking Statements
Any statements in this press release about future expectations, plans and prospects for Landos Biopharma, Inc. (the "Company"), including statements about the Company's strategy, clinical development of the Company's therapeutic candidates, the Company's anticipated milestones and future expectations and plans and prospects for the Company and other statements containing the words "subject to", "believe", "anticipate", "plan", "expect", "intend", "estimate", "project", "may", "will", "should", "would", "could", "can", the negatives thereof, variations thereon and similar expressions, or by discussions of strategy constitute forward-looking statements. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including: the uncertainties inherent in the initiation and enrollment of future clinical trials, expectations of expanding ongoing clinical trials, availability and timing of data from ongoing clinical trials, expectations for regulatory approvals, other matters that could affect the availability or commercial potential of the Company's product candidates and other similar risks. In addition, the forward-looking statements included in this press release represent the Company's views only as of the date hereof. The Company anticipates that subsequent events and developments will cause the Company's views to change. However, while the Company may elect to update these forward-looking statements at some point in the future, the Company specifically disclaims any obligation to do so, except as may be required by law. These forward-looking statements should not be relied upon as representing the Company's views as of any date subsequent to the date hereof.